Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-30 @ 7:06 PM
Study NCT ID:
NCT06769204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-10
First Post:
2025-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-02-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-08-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-07', 'studyFirstSubmitDate': '2025-01-07', 'studyFirstSubmitQcDate': '2025-01-07', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain during Cervical instrumentation of the tenaculum and cannula', 'timeFrame': '1 minute', 'description': 'pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt'}], 'secondaryOutcomes': [{'measure': 'pain At the end of uterine filling', 'timeFrame': '5 minutes', 'description': 'pain is measured using 10 cm VISUAL Analog scale where 0 denotes no pain and 10 maximum pain felt'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility', 'detailedDescription': 'We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women with Primary Infertility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.\n\nExclusion Criteria:\n\n* Known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray.\n* Current pregnancy or suspicion of pregnancy.\n* Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.\n* Use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.'}, 'identificationModule': {'nctId': 'NCT06769204', 'briefTitle': 'Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Safety and Efficacy of Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility', 'orgStudyIdInfo': {'id': 'LP SPRAY HSG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'lidocaine prilocaine', 'interventionNames': ['Drug: EMLA SPRAY']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'EMLA SPRAY', 'type': 'DRUG', 'otherNames': ['2 puffs into'], 'description': '2 puffs of lidocaine-prilocaine spray into the cervix and cervical canal 5 minutes before the procedure', 'armGroupLabels': ['lidocaine prilocaine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '2 puffs of saline into the cervix and cervical canal 5 minutes before the procedure', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'AHMED SAMY ALI ashour, MD', 'role': 'CONTACT', 'email': 'ahmedsamy8233@gmail.com', 'phone': '01100681167'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Ahmed Samy aly ashour', 'investigatorAffiliation': 'Cairo University'}}}}